On October 16, 2007, Medtronic issued a recall of approximately 268,000 Sprint Fidelis defibrillator leads. The reason for the recall is that after 30 months, the Sprint Fidelis leads had a fracture rate that was about twice as high as the previous model, the Sprint Quatro. Fractured leads can result in repeated unnecessary shocks, or worse — failure to detect a potentially fatal Cardiac Arrhythmia.
Medtronic is not recommending that the leads be replaced if there have been no problems because the replacement surgery operation hava greater risk of injury than the chances that someone’s leads will actually be defective. You will be able to tell if someone had the recalled leads implanted in them because everyone who was given a pacemaker/defibrillator should have an identification card that states the model and serial numbers of the device and leads.
On the card, this four (4) digit number will usually be followed by two or more digits and “1D.” However, you only need to focus on the first four (4) digits of the model number. Do not confuse the model number with the serial number. There are four model numbers that were recalled: 6930, 6931, 6948, and 6949.
If you, a family member or friend has a Medtronic Sprint Fidelis defibrillator with any of the above recalled model numbers, please fill out the form on the top of the page to be put in touch with an attorney who can explain what rights and options you have available.
For more information on this subject, please refer to the section on Medical Devices and Implants.
recently named in the 2009 edition of Best Lawyer's In America, David Mittleman has been representing seriously injured people since 1985. A partner with Church Wyble PC—a division of Grewal Law PLLC—Mr. Mittleman and his partners focus on medical malpractice, wrongful death, car accidents, slip and falls, nursing home injury, pharmacy/pharmacist negligence and disability claims.